The medtech industry called on EU policymakers to withdraw the proposed AI Liability Directive. Industry groups, including MedTech Europe and 11 other trade associations, argue that the directive could introduce unnecessary legal complexity and stifle investment in AI innovation. They point to the Draghi report on EU competitiveness, which recommends a streamlined legal framework to maintain the EU’s competitive edge.
These industry representatives note that the EU is already working with several legislative measures that affect AI — such as the AI Act, the General Date Protection Regulation (GDPR), the Cyber Resilience Act and others — as well as specific regulations for the medtech sector like the medical devices and in vitro diagnostic medical devices regulation. They contend that many national liability frameworks already address AI, particularly in consumer protection, so adding a new directive might be redundant.
The associations further argue that the impact of existing regulations, such as the AI Act and GDPR, has yet to be fully evaluated. They believe that the revised Product Liability Directive — which extends liability for defective products to include software and AI — will provide the necessary legal framework without the added burden of another directive. In their view, introducing the AI Liability Directive now could increase regulatory burdens and ultimately harm EU competitiveness by deterring investment.
It seems that the EU Commission eventually shares these concerns: On February 11, 2025, it put the AI Liability Directive on the list of proposals it intends to withdraw.
Source: Medtech Insight (an Informa product)
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